Review Memorandum

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE

A. 510(k) Number:

k082811

B. Purpose for Submission:

New device

C. Measurand:

Urine pH, blood, glucose, protein, ketone, urobilinogen, bilirubin, specific gravity, nitrite, ascorbic acid and leukocytes

D. Type of Test:

Qualitative and semi-quantitative

E. Applicant:

Urit Medical Electronic Co., Ltd.

F. Proprietary and Established Names:

Uritest 10G Urine Reagent Strips, Uritest 11G Urine Reagent Strips, Uritest 50 Urine Analyzer, Uritest -500B Urine Analyzer

G. Regulatory Information:

Classification Name Product Code Device Class Regulation Number Occult blood test JIO II 21 CFR §864.6550 Urinary glucose (non- JIL II 21 CFR §862.1340 quantitative) test system Urinary urobilinogen (non- CDM I 21 CFR §862.1785 quantitative) test system Urinary bilirubin and its JJB I 21 CFR §862.1115 conjugates (non- quantitative) test system Ketones (non-quantitative) JIN I 21 CFR §862.1435 test system

1 Urinary protein or albumin JIR I 21 CFR §862.1645 (non-quantitative) test system Nitrite (non-quantitative) JMT I 21 CFR §862.1510 test system Leukocyte peroxidase test LJX I 21 CFR §864.7675 Urinary pH (non- CEN I 21 CFR §862.1550 quantitative) test system Ascorbic acid test system JMA I 21 CFR §862.1095 Specific Gravity KSL I 21 CFR §864.9320 Automated Urinalysis KQO I 21 CFR §862.2900 System

4. Panel:

(75) Clinical Chemistry, (81) Hematology

H. Intended Use:

1. Intended use(s):

See indications for use below.

2. Indication(s) for use: The Uritest-50 and Uritest-500B urine analyzers are semi-automated, bench top instruments which are intended for prescription, in vitro diagnostic use only. The instruments perform semi-quantitative detection of the following analytes in urine: leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria. The instruments use the accompanying check strip for daily calibration.

Uritest 10G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood and pH in urine. The Uritest 10G urine reagent strips are for use with the Uritest-50 urine analyzer and are for prescription, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

Uritest 11G urine reagent strips provide semi-quantitative tests for leukocytes, ketone, nitrite, urobilinogen, bilirubin, protein, glucose, specific gravity, blood, pH and ascorbic acid in urine. The Uritest 11G urine reagent strips are for use with Uritest-500B urine analyzer and are for prescription, in vitro diagnostic use only. Test results may provide information regarding the status of carbohydrate metabolism, kidney and liver function, acid-base balance and bacteriuria.

2 3. Special conditions for use statement(s):

Prescription use only

The test strips are not to be used for visual reading.

4. Special instrument requirements:

Uritest 50 and Uritest 500B urine analyzers

I. Device Description:

The Uritest-50 and Uritest-500B Urine Chemistry Analyzers are reflectance spectrophotometers that measure the reflectance from a Uritest 10G or Uritest 11G urine reagent strip for urinalysis. Both devices can display and print urinalysis results and can be connected to a laboratory computer for data management. Both analyzers are capable of reading the ascorbic acid pad on the Uritest 11G strip.

Uritest 10G strips and the Uritest 11G are dry chemistry reagent strips for use in urine. Both strips measure urine glucose, pH, urobilinogen, bilirubin, protein, specific gravity, ketone, blood, leukocyte esterase and nitrite. The Uritest 11G can also measure ascorbic acid.

J. Substantial Equivalence Information:

Device Name Predicate Device Name Predicate 510(k) number Uritest 50 Bayer Clinitek 500 k926359 Uritest 500B Bayer Clinitek 500 k926359 Uritest 10 G Bayer Multistix 10 SG k052719 Uritest 11G Bayer Multistix 10 SG k052719 Uritest 11G (ascorbic acid) Diuri Uristik H-11 k040703 Uritest 50 (ascorbic acid) Diuri H-500 k040703 Uritest 500B (ascorbic acid) Diuri H-500 k040703

3. Comparison with predicate:

Predicate k040703 Item Device Predicate k926359 (ascorbic acid only) Uritest-50 Bayer Clinitek 500 Dirui H-500 Intended use For use with Uritest 10G and For use with Bayer For use with URISTK 11G urine reagent strips for Multistix 10 SG reagent H-11 reagent strips for the semi-quantitative strips for the semi- the qualitative or determination of Leukocytes, quantitative semi-quantitative Ketones, Nitrite, determination of determination of

3 Urobilinogen, Bilirubin, Leukocytes, Ketones, Urobilinogen, Bilirubin, Protein, Glucose, Specific Nitrite, Urobilinogen, Ketone (acetoacetic Gravity, Blood, pH and Bilirubin, Protein, acid), Blood, Protein, Ascorbic Acid. Glucose, Specific Nitrite, Leukocytes, Gravity, Blood and pH. Glucose, Specific Gravity, pH, and Ascorbic Acid. General Bench-top instrument Same Same design Operating Reflectance photometer Same Same principle Calibration Self-calibration---white Same Same calibration bar Specimen ID Manually enter or by bar Same Same enter code reader Printer Internal or external Same Same Throughput Single test mode: 60 500 tests/hour 514 strips/hour tests/hour Continuous test mode: 120 tests/hour Result report Semi-quantitative symbol, SI Same Same or Conventional unit and plus system Memory 1,000 results 500 patient results 2000 patient results 200 control results Environment 15°C-30°C, 18°C -30°C, 18°C -30°C, requirement RH ≤ 80% RH: 20% - 80% RH ≤ 80% Weight 2 Kg 7.4 Kg 6.8 Kg Dimension 290 mm X 200 mm X 100 324 mm X 377 mm X 380 mm X 378 mm X mm 282 mm 275 mm Power source DC 12V (Adapter), AC100- 100-240VAC ±10%, 50- 100~240VAC, 240V, 50/60Hz 60Hz. 50Hz/60Hz Power dissipation: 30VA Input: 72VA Power: 40VA

Predicate k040703 Item Device Predicate k926359 (ascorbic acid only) Uritest-500B Bayer Clinitek 500 Dirui H-500 Intended use For use with Uritest 10G and For use with Bayer For use with URISTK 11G urine reagent strips for Multistix 10 SG reagent H-11 reagent strips for the semi-quantitative strips for the semi- the qualitative or determination of Leukocytes, quantitative semi-quantitative Ketones, Nitrite, determination of determination of Urobilinogen, Bilirubin, Leukocytes, Ketones, Urobilinogen, Bilirubin, Protein, Glucose, Specific Nitrite, Urobilinogen, Ketone (acetoacetic acid), Gravity, Blood, pH and Bilirubin, Protein, Blood, Protein, Nitrite,

4 Ascorbic Acid. Glucose, Specific Leukocytes, Glucose, Gravity, Blood and pH. Specific Gravity, pH, and Ascorbic Acid. Design Bench-top instrument Same Same Operating Reflectance photometer Same Same principle Calibration Self-calibration---white Same Same calibration bar Specimen ID Manually enter or by bar Same Same enter code reader Printer Internal or external Same Same Throughput 500 tests/hour 500 tests/hour 514 strips/hour Result report Semi-quantitative symbol, SI Same Same or Conventional unit Memory 1,000 results 500 patient results 2000 patient results 200 control results Environment 15°C-30°C, 18°C -30°C, 18°C -30°C, requirement RH ≤ 80% RH: 20% - 80% RH ≤ 80% Weight 6.5 Kg 7.4 Kg 6.8 Kg Dimension 390 mm X 340 mm X 324 mm X 377 mm X 380 mm X 378 mm X 290 mm 282 mm 275 mm Power source AC100-240V, 50/60Hz 100-240VAC ±10%, 50- 100~240VAC, Input: 61VA 60Hz. Input: 72VA 50Hz/60Hz Power: 40VA

Reagent Strips Predicate k040703 Item Predicate k052719 (ascorbic acid only) Uritest 11G Bayer Multistix 10SG Dirui URISTIK H-11 Intended use For semi-quantitative For semi-qualitative For qualitative and determination of certain determination of semi-qualitative constituents in urine by certain constituents in determination of reflectance photometry urine either visually certain constituents in with Uritest-50 or Uritest- or by reflectance urine either visually or 500B Urine Analyzer. photometry with the by reflectance These measurements are Clinitek family Urine photometry with the useful in the evaluation of Analyzer. These Dirui H-100 and H- renal, urinary and measurements are 500 Urine Analyzers. metabolic disorders. useful in the These measurements are useful in the evaluation of renal, evaluation of renal, urinary and metabolic urinary and metabolic disorders. disorders. Analytes Leukocytes, Ketones, Leukocytes, Ketones, Leukocytes, Ketones, Nitrite, Urobilinogen, Nitrite, Urobilinogen, Nitrite, Urobilinogen,

5 Bilirubin, Protein, Bilirubin, Protein, Bilirubin, Protein, Glucose, Specific Gravity, Glucose, Specific Glucose, Specific Blood, pH and Ascorbic Gravity, Blood and Gravity, Blood, pH acid pH and Ascorbic acid Specimen Urine Same Same Architecture Firm plastic, dry reagent Same Same strips Test Ingredients that change Same Same principle color in reaction with analytes Storage Store at 2°C-30°C At temperatures At temperatures below 30°C do not below 30°C do not freeze. freeze.

-Item Predicate k052719 Uritest 10G Bayer Multistix 10 SG Intended use For semi-quantitative deter- For semi-qualitative determination of mination of certain constituents certain constituents in urine either in urine by reflectance visually or by reflectance photometry photometry with Uritest-50 or with the Clinitek family Urine Uritest-500B Urine Analyzer. Analyzer. These measurements are These measurements are useful useful in the evaluation of renal, in the evaluation of renal, urinary and metabolic disorders. urinary and metabolic disorders. Analytes Leukocytes, Ketones, Nitrite, Leukocytes, Ketones, Nitrite, Urobilinogen, Bilirubin, Protein, Urobilinogen, Bilirubin, Protein, Glucose, Specific Gravity, Glucose, Specific Gravity, Blood and Blood, and pH pH Specimen Urine Same Architecture Firm plastic, dry reagent strips Same Test Ingredients that change color in Same principle reaction with analytes Storage Store at 2°C-30°C At temperatures below 30°C do not freeze.

K. Standard/Guidance Document Referenced (if applicable):

EN 61000-3-2:2000+A2:A2005 Harmonic Current Test

EN 61000-3-3:1995+A1:2001, Voltage Fluctuations and Flicker Test

EN 61010-1:2001, Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use Part 1: General Requirements

6 L. Test Principle:

Uritest 50 and Uritest 500B

The Uritest 50 and Uritest 500B utilize reflectance photometry to measure the concentration of various urine chemical compounds and constituents. A urine wetted reagent strip is placed into the instrument(s) causing a color change in the test pads. The degree of color development on the pads is proportional to the concentration of the urine analyte. The strip passes under a LED light source. As the pad darkens in color, more light is absorbed and less is reflected. The reflected light is filtered at specific wavelengths corresponding to the reflected colors on the test pads. It is converted by the optical-electronic sensor system into electrical signals which are then converted into concentration units and printed.

Uritest 10G and Uritest 11G Test Strips

Leukocytes: The test reveals the presence of granulocyte esterases. These esterases cleave an indoxyl ester, and the indoxyl so liberated reacts with a diazonium salt to produce a violet dye. Leukocyte esterase results may be positive in the absence of observable cells if the leukocytes have lysed. Positive results may occasionally be found with random specimens from females due to contamination of the specimen by vaginal discharge. Elevated glucose concentrations (1000-2000mg/dL) or high specific gravity may cause decreased test results. The presence of cephalexin, cephalothin, tetracycline may cause decreased reactivity, and high levels of the drug may cause a false negative reaction. Reactivity may also vary with temperature. The test area does not react with lymphocyte. Ketone: This test is based on the principle of Legal’s test and is more sensitive to acetoacetic acid than to acetone. The reagent area does not react with β-hydroxybutyric acid. Some high specific gravity/low pH urines may give reactions up to and including Trace. Normal urine specimens usually yield negative results with this reagent. False positive results (Trace) may occur with highly pigmented urine specimens or those containing large amounts or levodopa metabolites. Nitrite: The test is based on the principle of Griess’s test and is specific to nitrite. Any degree of uniform pink colour development should be interpreted as a positive. Nitrite test area reacts singularly to the nitrite. Reacting color density does not correlate to number of existing bacteria. A negative result does not in itself prove that there is no significant bacteria. Negative results may occur when urinary tract infections are cause by organisms which do not contain reductase to convert nitrate to nitrite; when urine has not been retained in the bladder long enough (4-8hrs) for reduction of nitrate to occur; or when dietary nitrate is absent, even if organisms containing reductase are present and bladder incubation is ample. Ascorbic acid concentrations of 25mg/dL or greater may cause false negative results with specimens containing nitrite ion concentrations of 0.4mg/dL or less. Urobilinogen: This test is based on the Ehrlich reaction. The reagent area may react with interfering substances known to react with Ehrlich’s reagent. Excreted pigments and medicaments that have a red intrinsic coloration in acidic medium may produce false positive results. This test is inhibited by elevated concentrations of formaldehyde. Strip reactivity increases with temperature increasing； the optimum temperature is 22°C to 26°C. The absence of urobilinogen cannot be determined with this

7 test. Bilirubin: This test is based on the coupling of bilirubin with diazonium salt in an acid medium. Normally no bilirubin is detectable in urine by even the most sensitive methods. Even trace amounts of bilirubin are sufficiently abnormal to require further investigation. Some urine constituents (medicines, urinary indicants) may produce a yellowish or reddish discoloration of the test paper that may interfere with interpreting the result. Ascorbic acid concentrations of 100mg/dL or greater may cause false negatives. Protein: The test is based on the principle of the protein error of a pH indicator. The reagent area is more sensitive to albumin. An elevated pH (up to 9) may affect the test. The residues of disinfectants containing quaternary ammonium groups or chlorohexidine are present in the urine vessel maybe lead to a false positive result. Glucose: The test is based on the specific glucose oxidase/peroxidase reaction. The test is specific for glucose, no substance excreted in urine other than glucose is known to give a positive result. Ascorbic acid of more than 45mg/dL and/or high Ketone concentrations (80mg/dL) may cause false negatives for specimens containing small amounts of glucose (100mg/dL). The reactivity of the glucose test decreases as the SG of the urine increases. False positive reactions may be caused by hypochlorite or peroxide (cleaning agents). Reactivity may also vary with temperature. Specific Gravity: This test contains a detergent and Bromthymol blue that indicates the presence of ionic constituents in the urine by changing color from green to yellow. The specific gravity test permits determination of urine specific gravity between 1.005 and 1.030. In general, it correlates within 0.005 with values obtained with the refractive index method. Strips are automatically adjusted for pH by the instrument when pH≥7.0 or pH≤5.0. Highly buffered alkaline urine may cause low readings relative to other methods. Elevated specific gravity readings may be obtained in the presence of moderate quantities (500mg/dL) of protein. Blood: Hemoglobin and myoglobin catalyze the oxidation of the indicator by means of organic hydroperoxide contained in the test paper. This test is highly sensitive to hemoglobin and thus complements microscopic examination. The sensitivity of this test may be reduced in urine with high specific gravity. The test is equally sensitive to myoglobin as to hemoglobin. Captopril and Lodine may also cause decreased reactivity. Blood is often found in the urine of menstruating females. Certain oxidizing contaminants, such as hypochlorite, may produce false positive results. Microbial peroxidase associated with urinary tract infection may cause a false positive reaction. Ascorbic acid concentrations greater than 25mg/dL may cause false negatives at the trace levels. pH : This test contains a mixed indicator which assures a marked change in colour between pH4.5 and pH9. Ascorbic Acid (Uritest 11G only): The test involves the decolorization of Tillman’s reagent. False positive results may occur.

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

8 Repeatability (within run) precision of both analyzers was evaluated by using negative urines and spiked urines of known concentrations for each analyte. Each sample was tested 20 times across 3 instruments with the Uritest 10G or Uritest 11G strips for a total of 60 measurements at each concentration. All concentrations for all tests had 60 of 60 (100%) match at ± one color block.

Uritest 50 Test Expected Value Leukocyte (leu/mcL) - (0) ± (15) +1 (70) +2 (125) +3 (500) Exact agreement 60/60 60/60 54/60 60/60 60/60 ± 1 color block 60/60 60/60 60/60 60/60 60/60 Nitrite Negative Positive Exact agreement 60/60 60/60 ± 1 color block 60/60 60/60 Ketone (mg/dL) - (0) ± (5) +1 (15) +2 (40) +3 (≥ 80) Exact agreement 60/60 52/60 60/60 50/60 52/60 ± 1 color block 60/60 60/60 60/60 60/60 60/60 Blood (ery/mcL) - (0) ± (10) +1 (25) +2 (80) +3 (200) Exact agreement 60/60 60/60 60/60 60/60 52/60 ± 1 color block 60/60 60/60 60/60 60/60 60/60 Bilirubin (mg/dL) - (0) +1 (0.5) +2 (2) +3 (6) Exact agreement 60/60 56/60 60/60 54/60 ± 1 color block 60/60 60/60 60/60 60/60 Urobilinogen (EU/dL) Normal +1 (2.0) +2 (4.0) +3(≥ 8.0) Exact agreement 60/60 60/60 54/60 60/60 ± 1 color block 60/60 60/60 60/60 60/60 Protein (mg/dL) - (0) ± (15) +1 (30) +2 (100) +3 (300) Exact agreement 60/60 58/60 60/60 60/60 39/60 ± 1 color block 60/60 60/60 60/60 60/60 60/60 Glucose (mg/dL) - (0) ± (50) +1 (100) +2(250) +3(500) +4(≥ 1000) Exact agreement 60/60 52/60 60/60 48/60 60/60 60/60 ± 1 color block 60/60 60/60 60/60 60/60 60/60 60/60 Specific Gravity 1.005 1.010 1.015 1.020 1.025 1.030 % Exact agreement 60/60 53/60 60/60 52/60 40/60 60/60 % ± 1 color block 60/60 60/60 60/60 60/60 60/60 60/60 pH 5.0 6.0 7.0 8.0 8.5 9.0 Exact agreement 48/60 34/60 24/60 60/60 42/60 100 ± 1 color block 60/60 60/60 60/60 60/60 60/60 60/60 Ascorbic Acid (mg/dL) - (0) ± (10) +1 (25) +2 (50) +3 (100) Exact agreement 60/60 58/60 60/60 60/60 52/60 ± 1 color block 60/60 60/60 60/60 60/60 60/60

9 Uritest—500B Test Expected Value Leukocyte (leu/mcL) - (0) ± (15) +1 (70) +2 (125) +3 (500) Exact agreement 60/60 60/60 54/60 56/60 60/60 ± 1 color block 60/60 60/60 60/60 60/60 60/60 Nitrite Negative Positive Exact agreement 60/60 60/60 ± 1 color block 60/60 60/60 Ketone (mg/dL) - (0) ± (5) +1 (15) +2 (40) +3 (≥ 80) Exact agreement 60/60 50/60 60/60 48/60 58/60 ± 1 color block 60/60 60/60 60/60 60/60 60/60 Blood (ery/mcL) - (0) ± (10) +1 (25) +2 (80) +3 (200) Exact agreement 60/60 57/60 60/60 60/60 59/60 ± 1 color block 60/60 60/60 60/60 60/60 60/60 Bilirubin (mg/dL) - (0) +1 (0.5) +2 (2) +3 (6) Exact agreement 60/60 60/60 60/60 54/60 ± 1 color block 60/60 60/60 60/60 60/60 Urobilinogen (EU/dL) Normal +1 (2.0) +2 (4.0) +3(≥ 8.0) Exact agreement 60/60 58/60 60/60 60/60 ± 1 color block 60/60 60/60 60/60 60/60 Protein (mg/dL) - (0) ± (15) +1 (30) +2 (100) +3 (300) Exact agreement 60/60 60/60 60/60 60/60 45/60 ± 1 color block 60/60 60/60 60/60 60/60 60/60 Glucose (mg/dL) - (0) ± (50) +1 (100) +2(250) +3(500) +4(≥ 1000) Exact agreement 60/60 60/60 60/60 44/60 60/60 60/60 ± 1 color block 60/60 60/60 60/60 60/60 60/60 60/60 Specific Gravity 1.005 1.010 1.015 1.020 1.025 1.030 Exact agreement 60/60 48/60 60/60 58/60 45/60 60/60 ± 1 color block 60/60 60/60 60/60 60/60 60/60 60/60 pH 5.0 6.0 7.0 8.0 8.5 9.0 Exact agreement 42/60 60/60 58/60 60/60 34/60 60/60 ± 1 color block 60/60 60/60 60/60 60/60 60/60 60/60 Ascorbic Acid (mg/dL) - (0) ± (10) +1 (25) +2 (50) +3 (100) Exact agreement 60/60 60/60 60/60 60/60 56/60 ± 1 color block 60/60 60/60 60/60 60/60 60/60

Precision was determined using two levels of commercially available control material. One lot each of Uritest 10G and Uritest 11G strips was used on one Uritest- 50 and Uritest-500B. Tests were performed in replicates of 10 for 2 runs on each analyzer for 10 days.

10 Uritest-50 N=negative, P=positive Level 1 Level 2 % % Expected Test Expected Test Analyte Agreement n Agreement N values results values results

Leukocytes N N 100 400 ±-2+ ±-1+ 100 400 Ketone N N 100 400 ±-2+ 1+ 100 400 Nitrite N N 100 400 P P 100 400 Urobilinogen N N 100 400 2+-3+ 2+-3+ 100 400 Bilirubin N N 100 400 2+-3+ 3+ 100 400 Protein N N 100 400 2+-3+ 3+ 100 400 Glucose N N 100 400 2+-4+ 3+-4+ 100 400 Specific 1.010- 1.010- 1.015- 1.015- 100 400 100 400 Gravity 1.020 1.015 1.025 1.025 Blood N N 100 400 2+-3+ 3+ 100 400 pH 5.0-6.0 5.5-6.0 100 400 6.5-7.5 6.5-7.0 100 400

Uritest-500B N=negative, P=positive Level 1 Level 2 % % Expected Test Expected Test Analyte Agreement n Agreement N values results values results

b. Linearity/assay reportable range:

A study was performed to test the measuring range on the Uritest 50 analyzer and Uritest 500 analyzer using one lot of Uritest 10G and Uritest 11G strips in replicates of 10. Samples were created by spiking negative urine with known concentrations of each substance or by serial dilution of a high concentration with a negative urine. Specimens were adjusted the match the concentration for each particular color pad on

11 the strip. Negative samples were not tested. See section M.1.a. Repeatability studies for negative samples. Results are summarized below.

Uritest-50 with Uritest 10G Test Exact Match % ± 1 Color Block % pH 37/50 74 50/50 100 Glucose 38/50 88 50/50 100 Specific Gravity 56/60 93 60/60 100 Nitrite 10/10 100 10/10 100 Blood 34/40 85 40/40 100 Protein 37/40 93 40/40 100 Bilirubin 28/30 93 30/30 100 Urobilinogen 26/30 87 30/30 100 Ketone 37/40 93 40/40 100 Leukocyte esterase 37/40 93 40/40 100 Ascorbic acid (11G) 35/40 88 40/40 100

Uritest-500B with Uritest 11G Test Exact Match % ± 1 Color % Block pH 31/50 62 50/50 100 Glucose 38/50 88 50/50 100 Specific Gravity 54/60 88 60/60 100 Nitrite 10/10 100 10/10 100 Blood 34/40 85 40/40 100 Protein 39/40 98 40/40 100 Bilirubin 29/30 97 30/30 100 Urobilinogen 27/30 90 30/30 100 Ketone 40/40 100 40/40 100 Leukocyte esterase 33/40 83 40/40 100 Ascorbic acid 33/40 83 40/40 100

The reportable ranges for the Uritest -50 and Uritest-500B are: Test Reportable Range pH 5.0-9.0 Glucose Neg.-1000 mg/dL Specific Gravity 1.005-1.030 Nitrite Neg-Pos Blood Neg-200 ery/micL Protein Neg-300 mg/dL Bilirubin Neg-6 mg/dL Urobilinogen 2-8 E.U/dL Ketone Neg-80 mg/dL Leukocyte esterase Neg-500 leu/micL Ascorbic acid Neg -100 mg/dL

12 c. Traceability, Stability, Expected values (controls, calibrators, or methods):

The sponsor recommends using commercially available control materials for use on the Uritest 50 and Uritest-500B urine analyzers.

Calibration verification is performed using Check Strips which are included with the analyzers. These are white strips which check the remittance values for each test. Recommendations for calibration verification are included in the operator’s manual for each analyzer.

Real time stability studies were performed for the Uritest 10G and Uritest 11G test strips over a 21 month period. The test strips were stored at 2° C-8° C and 30° C. Strips were tested quarterly with negative and spiked positive urine samples on the Uritest 50 and Uritest 500 Urine Analyzers. Data demonstrated that the test strips met the sponsor’s claimed shelf-life of 18 months at 2°C-30°C and <= 80% Relative Humidity.

d. Detection limit:

Analytical sensitivities of the Uritest 10G and Uritest 11G strips on the Uritest 50 and Uritest-500B were evaluated by spiking urine with known concentrations of each analyte and then diluting these samples with a negative urine to establish the range where the strip went from negative readings to positive readings. Each concentration was tested 10 times on each analyzer using each strip type. The upper limit of sensitivity was defined as the cutoff at which 100% of the test results were trace or positive. The sensitivities for both analyzers and both strips were identical. pH and specific gravity do not have lower limits of sensitivity. See section M.1.b.

Analyte 10G 11G Sensitivity range Leukocytes Lowest Highest Lowest Highest 15-40 leu/mcL sensitivity sensitivity sensitivity sensitivity 15 leu/mcL 40 leu/mcL 15 leu/mcL 40 leu/mcL Uritest 50 Negative 2 0 3 0 Trace (15 cells/mcL) 8 10 7 10 Uritest 500B Negative 3 0 3 0 Trace (15 cells/mcL) 7 10 7 10 Ketone Lowest Highest Lowest Highest 5.0-10.0 mg/dL sensitivity sensitivity sensitivity sensitivity 5 mg/dL 10 mg/dL 5 mg/dL 10 mg/dL Uritest 50 Negative 2 0 2 0 Trace (5 mg/dL) 8 10 8 10 Uritest 500B Negative 1 0 1 0 Trace (5 mg/dL) 9 10 9 10

Nitrites Lowest Highest Lowest Highest 0.15-0.2 mg/dL sensitivity sensitivity sensitivity sensitivity (Neg/Pos) 0.15 mg/dL 0.2 mg/dL 0.15 mg/dL 0.2 mg/dL Uritest 50 Negative 1 0 2 0 Positive 9 10 8 10 Uritest 500B Negative 2 0 2 0 Positive 8 10 8 10 Urobilinogen Lowest Highest Lowest Highest 1.5-2.0 EU/dL sensitivity sensitivity sensitivity sensitivity 1.0 EU/dL 2.0 EU/dL 1.0 EU/dL 2.0 EU/dL Uritest 50 Negative 3 0 3 0 1+ (2 EU/dL) 7 10 7 10 Uritest 500B Negative 2 0 3 0 1+ (2 EU/dL) 8 10 7 10

Analyte 10G 11G Sensitivity range Bilirubin Lowest Highest Lowest Highest 0.5-1.0 mg/dL sensitivity sensitivity sensitivity sensitivity 0.5 mg/dL 1.0 mg/dL 0.5 mg/dL 1.0 mg/dL Uritest 50 Negative 3 0 3 0 1+ (0.5 mg/dL) 7 10 7 10 Uritest 500B Negative 5 0 4 0 1+ (0.5 mg/dL) 5 10 6 10 Blood Lowest Highest Lowest Highest 5-15 Ery/mcL sensitivity sensitivity sensitivity sensitivity 5 Ery/mcL 15 Ery/mcL 5 Ery/mcL 15 Ery/mcL Uritest 50 Negative 2 0 2 0 Trace (10 ery/micL) 8 10 8 10 Uritest 500B Negative 1 0 2 0 Trace (10 ery/micL) 9 10 8 10 Protein Lowest Highest Lowest Highest 10-30 mg/dL sensitivity sensitivity sensitivity sensitivity 10 mg/dL 30 mg/dL 10 mg/dL 30 mg/dL Uritest 50 Negative 7 0 8 0 Trace (15 mg/dL) 3 10 2 10 Uritest 500B Negative 8 0 8 0 Trace (15 mg/dL) 2 10 2 10 Glucose Lowest Highest Lowest Highest 40-50 mg/dL sensitivity sensitivity sensitivity sensitivity 40 mg/dL 50 mg/dL 40 mg/dL 50 mg/dL Uritest 50 Negative 2 0 2 0 Trace (50 mg/dL) 8 10 8 10 Uritest 500B Negative 1 0 2 0 Trace (50 mg/dL) 9 10 8 10

14 Ascorbic Acid Lowest Highest 10-14 mg/dL sensitivity sensitivity 10 mg/dL 14 mg/dL Uritest 50 Negative 5 0 Trace (10 mg/dL) 5 10 Uritest 500B Negative 4 0 Trace (10 mg/dL) 6 10

e. Analytical specificity:

Fresh negative urine was spiked with possible interfering substances at various interferent concentrations and analyzed in replicates of 10 using the Uritest 10G and 11G strips on the Uritest 50 and Uritest 500B analyzers. The concentration where interference is observed and its effect on various tests is summarized below:

Test Interfering substances Impact on test Leukocytes Elevated glucose(1000-2000 mg/dL) Lower reported leu/uL High specific gravity（ >1.025） Lower reported leu/uL Low temperature(<20℃) Lower reported leu/uL Ketone Levodopa metabolites False positive (Trace) Nitrite Ascorbic acid(>25mg/dL) False negative Urobilinogen Excreted pigment False positive Bilirubin Ascorbic acid(>100mg/dL) False negative Protein Elevated pH (up to 9) False positive Quaternary ammonium False positive Glucose Ascorbic acid (>45mg/dL) False negative High Ketone (80mg/dL) False negative Peroxide False positive Specific Elevated protein (>500mg/dL) High specific gravity gravity Blood Ascorbic acid(>25mg/dL) False negatives Microbial peroxidase False positive pH Bacterial contamination/overgrowth may False increase cause elevated pH Ascorbic Other reducing agents, specifically sodium False positive acid thiosulfate, cysteine

Interfering substances and their effects on the various reagent strip analytes are presented in the labeling.

15 f. Assay cut-off:

Not applicable

2. Comparison studies:

a. Method comparison with predicate device: The clinical study was performed at three different clinical sites over 10 days. Three intended users operated the devices at each site (n=9). 321 out-patients were enrolled in the study: 104 subjects at Site 1, 102 subjects at Site 2 and 115 subjects at Site 3. The users used the labeling to perform the testing.

The sponsor also used 19 spiked urine samples in the study (N=340). 5 spiked samples at the Site 1, 9 spiked samples at the Site 2 and 5 spiked samples at Site 3. Among these samples, about 25%~35% positive samples were covered for each analyte with majority of values at the cutoff. Both subject urine samples and spiked urine samples at each clinical site were tested both on Uritest 10G, Uritest 11G and Bayer Multistix 10SG using the respective urine analyzer for each system.

The comparisons were as follows with the following note below: Glucose has different test pad concentrations between the candidate devices and the predicate devices. The differences are summarized below: － ± 1+ 2+ 3+ 4+ Glucose Bayer 0 100 250 500 1000 ---- (mg/dL) Uritest 0 50 100 250 500 1000

In addition, the sponsor performed ascorbic acid comparisons between the Uritest 50 and the Uritest 500B against the Dirui H-500 Urine Analyzer (k040703) on 216 samples at three sites using three intended users per site. The site combined results are below: 1) Uritest-50 with Uritest 11G VS. Dirui H-500 Ascorbic Predicate device

Acid －(0) ±(10) 1+(25) 2+(50) 3+(100) 3+(100) 1 12 2+(50) 1 2 13 Proposed 1+(25) 1 16 2 device ±(10) 1 20 1 －(0) 144 2 Total 145 24 19 16 12 % Agreement (exact 99 83 84 81 100 match) % Agreement (±1 100 96 100 100 100 color block)

16 2) Uritest-500B with Uritest 11G VS. Dirui H-500

Predicate device Ascorbic Acid －(0) ±(10) 1+(25) 2+(50) 3+(100) 3+(100) 1 1 12 2+(50) 1 13 Proposed device 1+(25) 2 16 2 ±(10) 1 21 1 －(0) 144 1 Total 145 24 19 16 12 % Agreement (exact match) 99 88 84 81 100 % Agreement (±1 color 100 100 95 100 100 block)

3). Uritest-50 with Uritest 10G VS. Clinitek 500 with Multistix 10SG

Predicate device LEU － ± +1 +2 +3 +3 1 16 +2 6 13 1 Proposed +1 4 22 1 device ± 1 34 3 － 236 2 Total 237 40 31 15 17 % Agreement 99 85 71 87 94 (exact match) % Agreement (±1 100 100 100 100 100 color block)

Predicate device NIT － + Proposed + 91 device － 248 1 Total 248 92 % Agreement (exact match) 100 99 % Agreement (±1 color 100 100 block)

Predicate device KET － ± +1 +2 +3 +3 11 +2 1 9 Proposed +1 17 3 device ± 49 2 － 247 1 Total 247 50 20 12 11 % Agreement (exact 100 98 85 75 100 match) % Agreement (±1 color 100 100 100 100 100 block)

For occult blood, test results were: Predicate device BLD － ± +1 +2 +3 +3 19 +2 18 3 Proposed +1 17 5 1 device ± 39 5 － 220 12 1 Total 220 51 23 23 23 % Agreement (exact match) 100 76 74 78 83 % Agreement (±1 color 100 100 96 100 96 block)

Predicate device BIL － +1 +2 +3 +3 12 Proposed +2 19 1 device +1 51 1 － 252 4 Total 252 55 20 13 % Agreement (exact 100 93 95 92 match) % Agreement (±1 color 100 100 100 100 block)

18 Predicate device URO Normal +1 (2.0) +2 (4.0) +3 (≥8.0) (0.2/1.0) +3 11 Proposed +2 1 24 device +1 51 Normal 250 3 Total 250 55 24 11 % Agreement (exact 100 93 100 100 match) % Agreement (±1 color 100 100 100 100 block)

Predicate device PRO － ± +1 +2 +3 +3 15 +2 15 Proposed +1 16 4 device ± 46 3 2 － 232 6 1 Total 232 52 20 21 15 % Agreement (exact 100 88 80 71 100 match) % Agreement (±1 color 100 100 95 90 100 block)

Predicate device (mg/dl) GLU +3 － ± (100) +1 (250) +2 (500) (1000) +4 (1000) 13 +3 (500) 13 3 Proposed +2 (250) 1 15 2 device +1 (100) 31 1 (mg/dl) ± (50) 6 － 255 Total 255 38 16 15 16 % Agreement (exact match) 100 82 94 87 81 % Agreement (±1 color 100 100 100 100 100 block)

Predicate device SG 1.005 1.010 1.015 1.020 1.025 1.030 1.030 4 42 1.025 1 1 58 6 Proposed 1.020 10 71 7 device 1.015 4 41 21 1.010 4 45 2 2 1.005 15 6 Total 19 55 54 95 69 48 % Agreement (exact 79 82 76 75 84 88 match) % Agreement (±1 color 100 100 98 98 100 100 block)

Predicate device pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 9.0 4 8.5 5 8.0 1 6 7.5 4 12 Proposed 7.0 3 32 4 device 6.5 2 32 7 6.0 143 15 1 5.5 4 20 27 5.0 13 4 1 Total 17 24 173 50 44 17 6 5 4 % Agreement (exact match) 76 83 83 64 73 71 100 100 100 % Agreement (±1 color 100 100 99 100 99 100 100 100 100 block)

4). Uritest-500B with Uritest 11G VS. Clinitek 500 with Multistix 10SG

Predicate device LEU － ± +1 +2 +3 +3 16 +2 2 15 1 Proposed +1 3 24 device ± 1 35 5 － 236 2 Total 237 40 31 15 17 % Agreement (exact 99 88 77 100 94

20 match) % Agreement (±1 100 100 100 100 100 color block)

Predicate device NIT － + Proposed + 92 device － 248 Total 248 92 % Agreement (exact match) 100 100 % Agreement (±1 color 100 100 block)

Predicate device KET － ± +1 +2 +3 +3 11 +2 2 12 Proposed +1 16 device ± 49 2 － 247 1 Total 247 50 20 12 11 % Agreement (exact 100 98 80 100 100 match) % Agreement (±1 100 100 100 100 100 color block)

For occult blood, test results were: Predicate device BLD － ± +1 +2 +3 +3 20 +2 19 2 Proposed +1 1 18 3 1 device ± 43 4 1 － 220 7 1 Total 220 51 23 23 23 % Agreement (exact 100 84 78 83 87 match) % Agreement (±1 color 100 100 96 96 96 block)

Predicate device BIL － +1 +2 +3 +3 13 Proposed +2 19 device +1 1 54 1 － 251 1 Total 252 55 20 13 % Agreement (exact 99 98 95 100 match) % Agreement (±1 color 100 100 100 100 block)

Predicate device URO Normal +3 +1 (2.0) +2 (4.0) (0.2/1.0) (>=8.0) +3 11 Proposed +2 22 device +1 1 51 2 Normal 249 4 Total 250 55 24 11 % Agreement (exact 99 93 92 100 match) % Agreement (±1 color 100 100 100 100 block)

Predicate device PRO － ± +1 +2 +3 +3 15 +2 16 Proposed +1 1 16 3 device ± 44 3 2 － 232 7 1 Total 232 52 20 21 15 % Agreement (exact 100 85 80 76 100 match) % Agreement (±1 color 100 100 95 90 100 block)

Predicate device (mg/dl) GLU +3 － ± (100) +1 (250) +2 (500) (1000) +4 (1000) 15 +3 (500) 14 1 Proposed +2 (250) 2 15 1 device +1 (100) 32 1 (mg/dl) ± (50) 4 － 255 Total 255 38 16 15 16 % Agreement (exact 100 84 94 93 94 match) % Agreement (±1 color 100 100 100 100 100 block)

Predicate device SG 1.005 1.010 1.015 1.020 1.025 1.030 1.030 1 39 1.025 8 53 9 Proposed 1.020 20 78 13 device 1.015 5 34 9 2 1.010 4 43 1.005 15 7 Total 19 55 54 95 69 48 % Agreement (exact 79 78 63 82 77 81 match) % Agreement (±1 color 100 100 100 100 97 100 block)

Predicate device pH 5.0 5.5 6.0 6.5 7.0 7.5 8.0 8.5 9.0 9.0 4 8.5 4 8.0 5 1 7.5 12 1 Proposed 7.0 2 34 5 device 6.5 36 10 6.0 142 12 5.5 3 17 24 5.0 14 7 7

23 Total 17 24 173 50 44 17 6 5 4 % Agreement (exact 82 71 82 72 72 71 83 80 100 match) % Agreement (±1 color 100 100 96 100 100 100 100 100 100 block)

5. Summary of Data

Uritest-50 with Uritest 10G VS. Clinitek 500 with Multistix 10SG % % % % Agreement Agreement Agreement Agreement Analyte (within ±1 Analyte (within ±1 (exact (exact color color match) match) block) block) 100 94.4 100 97.9 Leukocytes Ketone (340/340) (321/340) (340/340) (333/340) 100 99.7 100 98.8 Nitrite Urobilinogen (340/340) (339/340) (340/340) (336/340) 100 98.2 99.1 95.3 Bilirubin Protein (340/340) (334/340) (337/340) (324/340) 100 96.2 Specific 99.1 80.0 Glucose (340/340) (327/340) Gravity (337/340) (272/340) 99.4 92.1 99.4 78.5 Blood pH (338/340) (313/340) (338/340) (267/340)

Uritest-500B with Uritest 11G VS. Clinitek 500 with Multistix 10SG % % % % Agreement Agreement Agreement Agreement Analyte (within ±1 Analyte (within ±1 (exact (exact color color match) match) block) block) 100 95.9 100 98.5 Leukocytes Ketone (340/340) (326/340) (340/340) (335/340) 100 100 100 97.9 Nitrite Urobilinogen (340/340) (340/340) (340/340) (333/340) 100 99.1 99.1 95.0 Bilirubin Protein (340/340) (337/340) (337/340) (323/340) 100 97.4 Specific 99.4 77.1 Glucose (340/340) (331/340) Gravity (338/340) (262/340) 99.1 94.1 97.9 78.8 Blood pH (337/340) (320/340) (333/340) (268/340)

b. Matrix comparison:

24 Not applicable, this device is only used with urine.

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):

4. Clinical cut-off:

Not applicable

5. Expected values/Reference range: Reference ranges were drawn from literature:

Ketone: < 5 mg/dL Nitrite: 0 mg/dL Urobilinogen: 0.2-1.0 EU/dL Bilirubin: 0 mg/dL Protein: < 15 mg/dL Glucose: < 50 mg/dL Specific Gravity: 1.010-1.025 Blood: < 10 ery/micL Ascorbic Acid: < 10 mg/dL

BIBLIOGRAPHY 1. "European Urinalysis Guidelines", The Scandinavian Journal of Clinical & Laboratory Investigation, Scand J Clin Lab Invest-Vol. 60-Supplement 231.2000. 2. "The Clinical Analysis of Urine Recent Period", The Science and Technology Publishing House, Yu Long Cong, Jun Long Ma, Editors; 1998; pp. 37-81, 96-97. 3. “Compendium – Urinalysis with Test Strips” Roche Diagnostic, Combur® Reagent Strips.’

N. Instrument Name:

Uritest-50 and Uritest 500B

O. System Descriptions:

1. Modes of Operation:

The Uritest 50 and Uritest-500B are automated urine analyzers using reflectance

25 spectroscopy for the semi-quantitative determination of pH, Specific Gravity, Protein, Glucose, Ketones, Urobilinogen, Bilirubin, Leukocyte esterase, Blood, Nitrite and Ascorbic Acid in urine samples. English is the default language.

2. Software:

FDA has reviewed applicant’s Hazard Analysis and software development processes for this line of product types:

Yes __X____ or No ______

3. Specimen Identification:

Numerical specimen identification information can be entered manually via a keypad on the analyzers, or it is available for use with a bar code scanner using the PS/2 port on the back of the instruments.

4. Specimen Sampling and Handling:

Uritest-50 analyzes one strip at a time. The user must wait for the completion of the strip before loading the next one.

Uritest 500B can analyze multiple strips. The user wets the test strip and places it on a sample tray. The analyzer pulls the strip inside to begin timing and analysis. The instrument prompts the user to wet another strip and put it on the tray thereby allowing multiple strips to be processed for analysis at one time.

5. Calibration:

Calibration is factory set, however a white calibration strip is used to check the remittance outputs of the LEDs in the read head. Labeling recommends that the user perform the calibration verification with the white strip after maintenance, with a new lot of strips, with a new bottle of strips, change of operator, or when there is a question with results.

6. Quality Control: QC is analyzed like the patient samples. The QC data is not stored separately from patient data, however both analyzers can be connected to a computer via a RS 232 port. Labeling recommends two levels of quality control need to be assayed according to state, federal and local guidelines and 1) after using the check strip, 2) after maintenance or service 3) when starting a new lot number of test strips, 4) when starting a new bottle of test strips 5) changing operator, 6) when there are questionable results, 7) every 30 days to check the storage conditions of the strips.

P. Other Supportive Instrument Performance Characteristics Data Not Covered In The “Performance Characteristics” Section above:

26 Q. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

R. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.